Dalli

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MedTech Forum 2012: "S is for scrutiny, which we're not sure about"

“S is for scrutiny, which we’re not sure about”, that would be more or less the take home message of the MedTech Forum in Brussels that I attended last week from Wednesday…

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What to expect in the new EU in vitro diagnostics regulation?

Our seminar on IVD legal and regulatory issues of 12 september was a big succes. We had the passionate story of Henk Viëtor about Skyline Diagnostics’ efforts to bring its products to…

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Update on Commission reaction to ENVI resolution – no PMA proposal on the table

In my previous post on this topic I wrote that it looked like the Commission had changed tack to propose a pre-market authorisation (PMA) for medical devices after all. It turns out that…

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It's official: the ENVI resolution is out in final version – EU Commission changes tack to propose PMA for devices

Some time ago I wrote about the proposed ENVI resolution that the the EU Parliament’s ENVI committee adopted in reaction to the PIP breast implants scandal in the EU. At that time…

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EU ENVI Parliamentary Committee resolution re Review : "learn the lessons of this fraud" and an FDA internal report

The European Parliament’s ENVI Committee (Committee on the Environment, Public Health and Food Safety) has added to the political pressure on the European Commission that is currently working on the proposal of…

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Marketing surveillance shaping up pre-Review with Dutch Minister feedback to Dalli Action Plan

Interesting developments after the joint plan for action that Commissioner Dalli sent to the member states in the beginning of February this year urging them to step up market surveillance in order to…

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The latest on the Recast, Review, Revision of EU medical devices framework

Whenever Ms Minor from DG SANCO speaks at an event, everyone in the medical devices industry listens, hoping for new elements about where the Commission is going with the recast, review or…

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